CSV Specialist – Regulated Lab Systems (GxP) | Hybrid

Kymos-Group; Bellprat; Híbrido; EUR 42.000 - 62.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Flexible working hours

23 vacation days + December days off

Employee benefits platform

Descripción de la vacante

KYMOS GROUP is seeking a Computer System Validation professional to join the CSV area based in Cerdanyola del Vallès, Barcelona, to support validation, maintenance, and review of computerized systems in GxP environments.

The role requires a university degree and knowledge of CSV lifecycle, with collaboration across Quality, IT, and Laboratory teams; bilingual Spanish/English preferred; hybrid schedule with majority on-site work at our offices near Collserola Park.

Formación

• University degree in Engineering, Chemistry, Physics, Pharmacy, or a related field.
• Previous experience, internships, or knowledge in computer system validation, quality, laboratory environments, IT, or regulated GxP environments.
• Familiarity with the computer system validation lifecycle and related documentation.
• Knowledge of regulations or guidelines such as GAMP 5, EU GMP Annex 11, 21 CFR Part 11, ISO, or GxP.
• Knowledge or experience with systems such as LIMS, Empower, SCADA, ERP, or other laboratory or corporate software.
• Ability to work collaboratively with technical departments, Laboratory, IT, and Quality Assurance teams.
• Strong organizational skills, attention to detail, and a compliance-oriented mindset.
• Advanced level of Spanish and English, both spoken and written.

Responsabilidades

• Participate in computer system validation activities, both for laboratory equipment and other systems.
• Support the preparation and review of validation documentation, such as Validation Plan, Risk Analysis, Design Review, IOPQ, Traceability Matrix, and Final Validation Report.
• Collaborate in the assessment of data integrity requirements, regulatory compliance, and change control.
• Support the preparation and execution of tests, test plans, and user acceptance testing.
• Participate in periodic reviews of computerized systems.
• Collaborate with Quality Assurance, IT, LIMS, and Laboratory teams on projects related to computerized systems.
• Support internal audits and the preparation of documentation related to CSV.

Conocimientos

Computer System Validation

Regulatory compliance

Documentation

Data integrity

Educación

University degree in Engineering, Chemistry, Physics, Pharmacy

Herramientas

LIMS

Empower

SCADA

ERP

Descripción del empleo

KYMOS GROUP is seeking a Computer System Validation professional to join the CSV area based in Cerdanyola del Vallès, Barcelona, to support validation, maintenance, and review of computerized systems in GxP environments.

The role requires a university degree and knowledge of CSV lifecycle, with collaboration across Quality, IT, and Laboratory teams; bilingual Spanish/English preferred; hybrid schedule with majority on-site work at our offices near Collserola Park.